Director, Quality Assurance and Regulatory Affairs

Director, Quality Assurance and Regulatory Affairs

Location: Mississauga, ON, Hybrid
Language: English, strong written and verbal communication required

This is an exciting opportunity for an experienced quality and regulatory leader to shape compliance, quality systems, and continuous improvement within a highly regulated healthcare logistics environment. Working at the intersection of quality, operations, and customer experience, youll help ensure products are stored and distributed safely, efficiently, and in accordance with Canadian regulatory requirements.

As Director, Quality Assurance and Regulatory Affairs, youll serve as a trusted advisor to senior leaders, operational teams, and customers. Youll lead a national quality function, strengthen quality culture, and apply a pragmatic, risk-based approach that balances compliance, service excellence, and patient safety.

Join a collaborative organization where quality is viewed as a strategic business partner. Youll have the opportunity to influence national quality strategy, develop high-performing teams, and contribute to continuous improvement across a complex healthcare logistics network. This permanent opportunity offers a salary range of $120,934 to $151,167, plus health and dental benefits, retirement savings, tuition reimbursement, training, and career development opportunities.

• Youll lead and continuously improve the QMS/eQMS across multiple sites, ensuring compliance with GMP, GDP, ISO standards, DEL/MDEL requirements, and controlled substances regulations.
• Youll oversee key quality processes including CAPA, deviations, change control, vendor qualification, document management, product release, complaints, recalls, returns, and destruction.
• Youll lead internal, customer, and regulatory audits, including remediation and ongoing compliance readiness.
• Youll oversee CSV, WMS compliance, facility and equipment qualification, temperature mapping, environmental monitoring, cold chain processes, excursion management, and packaging qualification.
• Youll partner with operations and commercial teams on risk-based decisions, customer implementations, RFPs, solution design, Quality Agreements, and business reviews.
• Youll lead and develop a national quality team while establishing KPIs, executive reporting, accountability, and continuous improvement through Lean and Six Sigma principles.

• Masters of Science
• Experience working with narcotics and substance control
• 15+ years of Quality Assurance and/or Regulatory Affairs experience within pharmaceutical, healthcare, or medical device environments.
• 6+ years of leadership experience managing multi-site teams and senior leaders.
• 5+ years of experience within regulated healthcare 3PL distribution or wholesale warehouse environments.
• Strong knowledge of Health Canada regulations, GxP standards, GMP, GDP, ISO requirements, DEL/MDEL licensing, and controlled substances compliance.
• Demonstrated experience with QMS/eQMS, CAPA, validation, cold chain compliance, WMS, and Computer System Validation (CSV).
• Proven ability to partner effectively with operations, customers, commercial teams, and senior leadership.

Were looking for a quality leader who understands that strong compliance and strong operations go hand in hand. Youll bring sound judgment, a practical risk-based mindset, and the leadership skills to build trust across teams while continuing to strengthen our quality culture.

We appreciate the time and effort all applicants invest in their submissions. Please note that only candidates shortlisted for this role will be contacted directly. However, your profile will remain under consideration for future opportunities that align with your experience and career goals. All qualified applicants will receive fair consideration for employment. We welcome individuals of all backgrounds, experiences, and identities including those who identify as women, members of racialized groups, Indigenous Peoples, persons with disabilities, and 2

SLGBTQIA+ communities. If you require an accommodation, please review our accessibility policy and reach out to our accessibility officer with any questions. Our human recruiters review all applications and always make the final hiring decision. On occasion, we also use AI-assisted tools to help review applications.